Associate Director, CMC Project Mgmt – Early-Stage Programs

Vir-Biotechnology; San Francisco (CA); Hybrid; USD 163,000 - 228,000; Full time

Benefits offered by this job

Health and welfare benefit plans

401K match

Lunch in the office

Job summary

Vir Biotechnology, a clinical-stage biopharmaceutical company, seeks an Associate Director of CMC Project Management to lead cross-functional CMC programs from early development through regulatory filings and lifecycle management.

Based in San Francisco, the role requires onsite presence three days a week and close collaboration with Process Development, Analytical Development, Quality, Regulatory, and Supply Chain teams.

Qualifications

• BS or MS in Biotechnology, Chemical Engineering, Biology, Chemistry or related field; PhD, MBA or PMP/PMI preferred.
• 10+ years in CMC Development, CMC Regulatory Affairs, Quality, Technical Operations or related biotech/pharma fields.
• At least 5 years in project/program management for drug development programs.

Responsibilities

• Lead cross-functional CMC development programs from early to late-stage development, tech transfer, regulatory filings and lifecycle management.
• Develop and execute integrated project plans with external partners, CMOs and vendors.
• Drive risk identification, mitigation and scenario planning to support execution.
• Facilitate communication across CMC functions to align priorities, timelines and resources.
• Perform critical path analyses and identify opportunities to accelerate timelines and reduce risk.
• Standardize reporting and portfolio management processes across CMC teams.

Skills

Cross-functional leadership

Program management

Communication skills

Risk assessment

Education

BS or MS in Biotechnology, Chemical Engineering, Biology, Chemistry

Job description

Vir Biotechnology, a clinical-stage biopharmaceutical company, seeks an Associate Director of CMC Project Management to lead cross-functional CMC programs from early development through regulatory filings and lifecycle management.

Based in San Francisco, the role requires onsite presence three days a week and close collaboration with Process Development, Analytical Development, Quality, Regulatory, and Supply Chain teams.